Hypercholesterolemia
Conditions
Keywords
Lipitor, HMG-CoA reductase inhibitor
Brief summary
This study is to evaluate the controlling effect of atrovastatin on plasma lipid to achieve the category-specific targeted lipid levels.
Detailed description
To confirm the low-density lipoprotein cholesterol (LDL-C)-lowering effect of 24 weeks of treatment with Lipitor®(Generic Name : atorvastatin calcium) Tablets and determine the rate of achievement of the category-specific target LDL-C level in patients with hypercholesterolemia; and to confirm the usefulness (efficacy and safety) of atorvastatin in patients who have not responded sufficiently to other statin therapies
Interventions
DRUGatrovastatin
oral
Sponsors
Astellas Pharma Inc
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
Patients with hypercholesterolemia who have not achieved the category-specific target lipid level
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in rate of achievement of the category-specific target LDL-C level | 0, 4, 12 and 24 week |
| Changes in plasma LDL-C concentration | 0, 4, 12 and 24 week |
Secondary
| Measure | Time frame |
|---|---|
| Change in plasma lipid values (LDL cholesterol, HDL cholesterol, triglycerides, total cholesterol, and malondialdehyde-modified LDL [MDL-LDL]) | 0, 4, 12 and 24 week |
| Changes in renal function test values (urinary albumin, urinary creatinine, urinary protein, and serum creatinine) | 0, 4, 12 and 24 week |
Countries
Japan
Outcome results
None listed